SITAGLIN (Maple Healthcare Pty Ltd)
Product name
SITAGLIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
131 (175 working days)
Active ingredients
sitagliptin hydrochloride monohydrate
Registration type
New generic medicine
Indication
SITAGLIN/ SITAGLIPTIN MYLAN/ SITAGLIPTIN MAPLE (sitagliptin hydrochloride monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:
- monotherapy when metformin is considered inappropriate due to intolerance; or
- in combination with other anti-hyperglycaemic agents, including insulin [see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies].